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Formulation QA Assistant Engineer

Plats Wuxi, Jiangsu Sheng, Kina Jobb-id R-100694 Datum inlagd 02/18/2021

Responsibilities:

- Onsite inspection, identify potential risk, help enhance the quality sense of the operator

- Handling, investigation and assessing of quality issues

- Establish, execute and track CAPA

- Review batch production report

- To be involved in regulatory inspections and self-inspection

- Ensure to fulfil the KPIs of QA

- Support PET business processes regarding compliance and quality

- Identify the quality risk during daily work, improve continuously

- Communicate with other AZ sites regarding to quality issues

- Release GF and CMO products

- To maintain a smooth product release procedure

- Draft and review document to make sure in compliance with GMP requirement

- Annual product review

- Lead and execute Change Control

- Quality continuous improvement

- SHE responsibilities

Requirements:

- University graduate, major in pharmaceutical or related subjects

- 3 years plus experience as quality assurance

- Good GMP and quality system management knowledge

- Knowledge of process control methodology and statistics, for example Cpk, FMEA

- Knowledge of product process and typical equipment

- Working knowledge of Microsoft applications, SAP or similar system

- Good English

- Good Computer skill

- Good communication skills, strong quality minds and strong service minds



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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